Shots: Roche launches the cobas PIK3CA mutation test for patients with advanced/ m-BC in countries accepting the CE mark The IVT test is a real-time PCR test for the qualitative […]readmore
Tags : breast
Shots: The recommendation is based on a P-II DESTINY-Breast01 study assessing trastuzumab deruxtecan in patients with HER2 positive unresectable/ m-BC prior treated with trastuzumab emtansine The trial demonstrated a meaningful […]readmore
Shots: The pivotal P-III MONALEESA-7 study assessing Kisqali + endocrine therapy vs PBO + endocrine therapy, in pre- & perimenopausal women with HR+/HER2- advanced or metastatic-BC The study met its […]readmore
Biosimilars
Regulatory
Biocon and Mylan’s Ogivri (trastuzumab, biosimilar) Receives Health Canada’s Approval
Shots: The approval is based on study assessing Ogivri vs Herceptin (trastuzumab) in patients evaluating its safety, efficacy, PK and immunogenicity The study resulted with no clinical difference in safety, […]readmore
Shots: Roche’s Ventana HER2 Dual ISH DNA Probe Cocktail assay is used to detect HER2 biomarker in breast and gastric cancer patients receiving Herceptin (trastuzumab) The approval of Ventana HER2 […]readmore
Biosimilars
Biotech
Samsung Bioepis’ Biosimilar Transtuzumab Ontruzant (transtuzumab,dttb), Receives US FDA Approval
Shots: The US FDA has approved Ontruzant for all eligible indication vs reference Herceptin(transtuzumab), for adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal […]readmore